PANTOPRAZOLE QUALIGEN 40 MG GASTRO-RESISTANT TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PantoprazolQualigen 40 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What PantoprazolQualigen is and what it is used for
2. What you need to know before taking PantoprazolQualigen
3. How to take PantoprazolQualigen
4. Possible adverse effects
5. How to store PantoprazolQualigen
6. Contents of the pack and other information

1. What Pantoprazol Qualigen is and what it is used for

Pantoprazole is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

Pantoprazole is used for:

Adults and adolescents from 12 years of age:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before taking Pantoprazole Qualigen

Do not take Pantoprazole Qualigen

• If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.

• If you have low body stores of vitamin B12 or risk factors for this, and are receiving pantoprazole treatment for a long period. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.

• Talk to your doctor if you are taking a medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole.

• If you are taking proton pump inhibitors such as pantoprazole, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

• If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole used to reduce stomach acidity.

• If you are scheduled to have a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Inform your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anemia)
• Blood in your stools
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor may monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events during each visit.

Other medicines and Pantoprazole Qualigen

Pantoprazole may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used for certain types of cancer), as pantoprazole may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pantoprazole is unlikely to affect your ability to drive or use tools or machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or operate machinery.

Pantoprazole Qualigen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free".

3. How to take Pantoprazol Qualigen

Follow exactly the instructions for use provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

When and how should you take Pantoprazol Qualigen?

Take the tablets whole, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has prescribed otherwise, the usual dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to two tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will inform you of how long you should take this medicine.

For the treatment of an infection caused by a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, along with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily together with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics.

The treatment duration is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day. Your doctor may double the dose.

Your doctor will inform you of how long you should continue treatment. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion:

The recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If more than two tablets per day are prescribed, you should take them divided into two daily doses.

If you are prescribed more than four tablets per day, you will be given specific instructions on when to stop treatment.

Special patient groups:

• If you have kidney problems or moderate to severe liver problems, you should not take pantoprazole for Helicobacter pylori eradication.

• If you have severe liver impairment, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazol Qualigen than you should

Inform your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazol Qualigen

Do not take a double dose to make up for missed doses. Take your next dose as usual.

If you stop taking Pantoprazol Qualigen

Do not stop taking these tablets without first consulting your doctor or pharmacist.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

The frequency of the possible adverse effects described below is classified as follows:

• very common (may affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• very rare (may affect up to 1 in 10,000 people)
• frequency not known (frequency cannot be estimated from the available data).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist or contact the nearest hospital emergency service.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, skin rash (urticaria), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known): blisters on the skin and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, enlargement of the kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation).

Other adverse effects are:

• Common

Benign gastric polyps

• Uncommon

headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances.

• Rare

vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increase in body temperature; swelling in the limbs (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

• Very rare

disorientation

• Frequency not known

Hallucination, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood, sensation of tingling, prickling, paraesthesia (tingling), burning, numbness or inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon

increase in liver enzymes

• Rare

increase in bilirubin; increase in blood fat levels

• Very rare

reduction in the number of platelets, which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections.

Frequency not known:

Skin rash, possibly with joint pain.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister pack: Do not store above 30°C.

Bottle: No special storage conditions required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Qualigen

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components (excipients) are:

Core: Anhydrous disodium phosphate, mannitol (E-421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating: Hypromellose, triethyl citrate, sodium starch glycolate (derived from potato), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Yellow, oval-shaped, concave, smooth gastro-resistant tablet.

Packaging:

Bottles (high-density polyethylene container with low-density polyethylene screw cap provided with desiccant) and blisters (Alu/Alu blisters).

Packs containing 28 gastro-resistant tablets.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, c/C, nº 4

50016 Zaragoza

Spain

Date of the most recent review of this leaflet: June 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/